Adverse Drug Reaction Classification System

         

Pharmaceutical Information
Drug Name Dabigatran
Drug ID BADD_D00563
Description Dabigatran is the active form of the orally bioavailable prodrug [dabigatran etexilate].
Indications and Usage Not Available
Marketing Status approved; investigational
ATC Code B01AE07
DrugBank ID DB14726
KEGG ID D09707
MeSH ID D000069604
PubChem ID 216210
TTD Drug ID D0M7JT
NDC Product Code 51869-0030
UNII I0VM4M70GC
Synonyms Dabigatran | N-((2-(((4-(aminoiminomethyl)phenyl)amino)methyl)-1-methyl-1H-benzimidazol-5-yl)carbonyl)-N-2-pyridinyl-beta-alanine | BIBR 1048 | Pradaxa | Dabigatran Etexilate | Etexilate, Dabigatran | Dabigatran Etexilate Mesylate | Etexilate Mesylate, Dabigatran | Mesylate, Dabigatran Etexilate
Chemical Information
Molecular Formula C25H25N7O3
CAS Registry Number 211914-51-1
SMILES CN1C2=C(C=C(C=C2)C(=O)N(CCC(=O)O)C3=CC=CC=N3)N=C1CNC4=CC=C(C=C4)C(=N)N
Chemical Structure
ADRs Induced by Drug
*The priority for ADR severity classification is based on FAERS assessment, followed by the most severe level in CTCAE rating. If neither is available, it will be displayed as 'Not available'.
**The 'Not Available' level is hidden by default and can be restored by clicking on the legend twice.
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Spinal cord compression17.10.01.0060.000783%
Spleen disorder01.09.02.0030.000245%-
Splenic infarction01.09.02.004; 24.04.08.0240.000734%-
Stress ulcer07.04.04.0070.000245%-
Subarachnoid haemorrhage12.01.10.011; 17.08.01.010; 24.07.04.0040.016637%-
Subcutaneous emphysema12.02.06.002; 23.07.04.0060.000367%
Sudden death02.03.04.013; 08.04.01.0030.001468%
Superior vena cava syndrome16.32.03.019; 24.04.09.0080.000245%
Surgery25.01.02.003---
Syncope02.11.04.015; 17.02.04.008; 24.06.02.0120.013334%
Testicular swelling21.13.01.0030.000538%-
Thrombocytopenia01.08.01.002---
Thrombocytopenic purpura01.08.01.003; 23.06.01.0070.000245%-
Thrombocytosis01.08.02.0010.000905%-
Thrombophlebitis24.01.02.0010.000856%-
Thrombosis24.01.01.0060.031243%-
Thrombosis mesenteric vessel07.15.02.004; 24.01.08.0010.000367%-
Thrombotic stroke17.08.01.021; 24.01.04.0060.001223%-
Thyroid neoplasm05.02.05.002; 16.24.01.0020.000245%-
Transient ischaemic attack17.08.04.001; 24.04.06.0050.045555%
Transitional cell carcinoma16.08.04.002; 20.08.01.0100.000245%-
Ulcer08.03.06.0010.003205%-
Upper gastrointestinal haemorrhage07.12.02.006; 24.07.02.0240.020527%
Ureteric obstruction20.06.01.0050.000245%-
Urine flow decreased20.02.02.0120.000538%-
Urticaria10.01.06.001; 23.04.02.001--
Uterine haemorrhage21.07.01.005; 24.07.03.0040.000979%
Varicose vein24.10.04.0010.002447%-
Vasculitis10.02.02.006; 24.12.04.0270.002642%
Vena cava thrombosis24.01.10.0010.000856%-
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